Safety and Efficacy of Dexmedetomidine Nasal Spray for Pre-anaesthetic Sedation in Children: A Randomised, Double-Blinded, and Placebo-Controlled Trial

Abstract Background Off-label intranasal administration of dexmedetomidine injection has been widely applied in the pediatric sedation setting. We developed a dexmedetomidine nasal spray for pediatric pre-anaesthetic sedation. Objective To evaluate the pre-anaesthetic sedation efficacy and safety of the dexmedetomidine nasal spray in children. Methods Subjects between 2 and 6 years who were to undergo selective surgery were randomized to receive dexmedetomidine nasal spray or placebo in a 2:1 ratio. The dosage was 30 µg or 50 µg based on the body weight. The primary outcome measure was the proportion of subjects who achieved successful child-parent separation and were with Ramsay scale ≥ 3 within 45 min after administration. Secondary outcome measures included the proportions of subjects reaching successful parental separation, with Ramsay scale ≥ 3 at least once and UMSS ≥ 2 at least once within 45 min after administration, and the time from administration to the first time reaching Ramsay scale ≥ 3 and UMSS ≥ 2,. Safety was monitored via the assessments of adverse events, blood pressure, heart rate, respiratory rate and blood oxygen saturation. Results The proportion of subjects achieving successful parental separation and with Ramsay scale ≥ 3 within 45 min after administration was significantly higher in the dexmedetomidine group (94.4%) vs the placebo group (32.0%) ( P < 0.0001). As compared with placebo, dexmedetomidine treatment led to more subjects achieving Ramsay scale ≥ 3 or UMSS ≥ 2, and shorter time to reach successful parental separation, Ramsay scale ≥ 3 and UMSS ≥ 2 (all P < 0.0001). Adverse events were reported in 90.7% and 84.0% of subjects in the dexmedetomidine and placebo groups, respectively, and all the events were mild or moderate in severity. Conclusions Dexmedetomidine nasal spray presented effective pre-anaesthetic sedation in children with a favorable safety profile. Trial registration: Clinicaltrials.gov, identifier: NCT05111431(First registration date: 20/10/2021)